MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number SONATA

Device Problem Migration (4003)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 06/13/2017

Event Type  malfunction  

Event Description

The user's hearing performance with the device is affected.There was facial nerve stimulation due to active extra-cochlear channels reported.Therefore affected channels have been globally disabled on (b)(6) 2022.

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

The user's hearing performance with the device is affected.There was facial nerve stimulation due to active extra-cochlear channels reported.Therefore, affected channels have been globally disabled on (b)(6) 2022.Re-insertion surgery was performed on (b)(6) 2022.

Manufacturer Narrative

Additional information: based on the received information from the field, the device does not provide sufficient benefit due to a partial migration of the active electrode out of cochlea, as confirmed by post-operative diagnostic imaging.Further, the recipient experienced facial nerve stimulation most likely due to electrical stimulation in the middle ear caused by the extra-cochlear channels.A contribution of the observed fibrosis cannot be excluded.Reportedly, re-insertion surgery was tried but only four electrode contacts could be inserted due to ossification.The recipient has some hearing impression.The device remains implanted and in use.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 15066374
• MDR Text Key: 296246173
• Report Number: 9710014-2022-00515
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737049157
• UDI-Public: (01)09008737049157
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/20/2020
• Device Model Number: SONATA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Sex: Female